Mu gushushanya icyumba cya farumasi cya GMP, sisitemu ya HVAC nicyo kintu cyambere. Birashobora kuvugwa ko niba kugenzura ibidukikije mucyumba gisukuye bishobora kuzuza ibisabwa ahanini biterwa na sisitemu ya HVAC. Ubushyuhe bwo guhumeka no guhumeka (HVAC) byitwa kandi uburyo bwo kweza ikirere mu cyumba cya farumasi cya GMP. Sisitemu ya HVAC itunganya cyane cyane ikirere cyinjira mucyumba kandi ikagenzura ubushyuhe bw’ikirere, ubuhehere, uduce duto twahagaritswe, mikorobe, itandukaniro ry’umuvuduko n’ibindi bipimo byerekana aho imiti ikorerwa mu rwego rwo kureba niba ibipimo by’ibidukikije byujuje ibyangombwa by’imiti kandi birinda ko habaho ihumana ry’ikirere no kwambuka -kwanduza mugihe utanga ibidukikije byiza kubakoresha. Byongeye kandi, imiti isukuye ya farumasi ya sisitemu ya HVAC irashobora kandi kugabanya no gukumira ingaruka mbi zibiyobyabwenge ku bantu mugihe cyo gukora, no kurengera ibidukikije.
Muri rusange igishushanyo mbonera cya sisitemu yo kweza
Igice rusange cya sisitemu yo kweza ikirere hamwe nibiyigize bigomba gutegurwa hakurikijwe ibidukikije. Igice gikubiyemo cyane cyane ibice bikora nko gushyushya, gukonjesha, guhumeka, kwangiza, no kuyungurura. Ibindi bice birimo umuyaga mwinshi, gusubiza umuyaga wikirere, sisitemu yo kugarura ingufu zubushyuhe, nibindi. Ntabwo hagomba kubaho ibintu bigwa mumiterere yimbere ya sisitemu ya HVAC, kandi icyuho kigomba kuba gito gishoboka kugirango wirinde ivumbi. Sisitemu ya HVAC igomba kuba yoroshye kuyisukura no kwihanganira fumigasi ikenewe no kuyanduza.
1. Ubwoko bwa sisitemu ya HVAC
Sisitemu yo kweza ikirere irashobora kugabanywamo sisitemu yo guhumeka DC hamwe na sisitemu yo guhumeka. Sisitemu yo guhumeka ya DC yohereza umwuka wo hanze utunganijwe ushobora kuzuza ibisabwa mucyumba, hanyuma ugasohora umwuka wose. Sisitemu ikoresha umwuka mwiza wo hanze. Sisitemu yo guhumeka neza, ni ukuvuga ko ibyumba bisukuye byumuyaga bivangwa nigice cyumuyaga mwiza wo hanze wavuwe hamwe nigice cyumuyaga ugaruka uvuye mucyumba gisukuye. Kubera ko sisitemu yo guhumeka izenguruka ifite ibyiza byo gushora imari mike hamwe nigiciro gito cyo gukora, sisitemu yo guhumeka ikirere igomba gukoreshwa muburyo bushoboka bwose mugushushanya uburyo bwo guhumeka. Umwuka mu bice bimwe na bimwe by’umusaruro ntushobora gukoreshwa, nk'icyumba gisukuye (agace) aho imyanda isohoka mu gihe cyo kubyara umusaruro, kandi kwanduza kwanduzanya ntibishobora kwirindwa iyo umwuka wo mu nzu uvuwe; ibishishwa kama bikoreshwa mubikorwa, kandi kwirundanya gaze bishobora gutera ibisasu cyangwa umuriro hamwe ninzira mbi; ahakorerwa ibikorwa bya virusi; ahantu hakorerwa imiti ya radiyo ikora; uburyo bwo kubyara butanga ibintu byinshi byangiza, impumuro cyangwa imyuka ihindagurika mugihe cyibikorwa.
Ahantu hakorerwa imiti hashobora kugabanywamo ibice byinshi bifite isuku itandukanye. Ahantu hatandukanye hasukuye hagomba gushyirwaho ibikoresho byigenga bitwara ikirere. Buri sisitemu yo guhumeka itandukanijwe kumubiri kugirango irinde kwanduzanya ibicuruzwa. Ibice byigenga bitwara ikirere birashobora kandi gukoreshwa mubice bitandukanye byibicuruzwa cyangwa gutandukanya ahantu hatandukanye kugirango bitandukanya ibintu byangiza binyuze mu kuyungurura ikirere kandi bikarinda kwanduzanya binyuze muri sisitemu y’imyuka y’ikirere, nk'ahantu hakorerwa ibicuruzwa, ahakorerwa imirimo ifasha, ahabikwa, mu buyobozi, n'ibindi. . igomba kuba ifite ibikoresho bitandukanye byo gutwara ikirere. Ahantu ho gukorerwa hafite ibikorwa bitandukanye byo guhinduranya cyangwa ibihe byo gukoresha hamwe nibitandukaniro rinini mubisabwa n'ubushyuhe bwo kugenzura, sisitemu yo guhumeka nayo igomba gushyirwaho ukwayo.
2. Imikorere n'ingamba
(1). Gushyushya no gukonja
Ibidukikije bibyara umusaruro bigomba guhuzwa nibisabwa kubyara umusaruro. Mugihe nta bisabwa bidasanzwe byogukora imiti, ubushyuhe bwubushyuhe bwicyiciro cya C nicyiciro cya D burashobora kugenzurwa kuri 18 ~ 26 ° C, kandi ubushyuhe bwicyumba cyicyiciro cya A nicyiciro cya B gishobora kugenzurwa kuri 20 ~ 24 ° C. Muri sisitemu yo guhumeka ibyumba bisukuye, ibishishwa bishyushye nubukonje hamwe nudusanduku twoherejwe nubushyuhe, gushyushya amashanyarazi ya tubular, nibindi birashobora gukoreshwa mu gushyushya no gukonjesha ikirere, no kuvura umwuka mubushyuhe busabwa nicyumba gisukuye. Iyo ingano yumwuka mwinshi ari nini, gushyushya umwuka mwiza bigomba gutekerezwa kugirango birinde ibishishwa byo hepfo bikonje. Cyangwa ukoreshe ibishishwa bishyushye nubukonje, nkamazi ashyushye nubukonje, amavuta yuzuye, Ethylene glycol, firigo zitandukanye, nibindi mugihe ugena ibishishwa bishyushye nubukonje, ibisabwa kugirango ushushe ikirere cyangwa gukonjesha, ibisabwa nisuku, ubuziranenge bwibicuruzwa, ubukungu, n'ibindi. Hitamo ukurikije igiciro nibindi bisabwa.
(2). Ubushuhe no gutesha agaciro
Ubushuhe bugereranije bw'icyumba gisukuye bugomba kuba buhuye nibisabwa mu bya farumasi, kandi ibidukikije bikorerwamo ibya farumasi no guhumuriza ababikora. Iyo nta bisabwa bidasanzwe by’umusaruro w’imiti, ubuhehere bugereranije bw’icyiciro cya C n’icyiciro cya D bugenzurwa kuri 45% kugeza kuri 65%, naho ubuhehere bugereranije bw’icyiciro cya A n’icyiciro cya B bugenzurwa kuri 45% kugeza kuri 60% .
Ibicuruzwa byifu ya sterile cyangwa imyiteguro myinshi ikomeye bisaba umusaruro muke ugereranije nibidukikije bitanga umusaruro. Dehumidifiers na post-coolers zirashobora gufatwa kugirango ziveho. Bitewe nishoramari ryinshi nigiciro cyo gukora, ubushyuhe bwikime busanzwe bukenera kuba munsi ya 5 ° C. Ibidukikije bitanga umusaruro hamwe nubushuhe buhebuje birashobora kubungabungwa ukoresheje amavuta yinganda, amavuta meza yateguwe mumazi meza, cyangwa binyuze mumashanyarazi. Iyo icyumba gisukuye gifite ubushyuhe bugereranije, umwuka wo hanze mugihe cyizuba ugomba gukonjeshwa na cooler hanyuma ugashyuha nubushyuhe kugirango uhindure ubushuhe bugereranije. Niba amashanyarazi ahamye murugo agomba kugenzurwa, ubushuhe bugomba gutekerezwa mubihe bikonje cyangwa byumye.
(3). Muyunguruzi
Umubare wumukungugu wumukungugu hamwe na mikorobe mukirere cyiza no kugaruka birashobora kugabanuka kugeza byibuze binyuze muyungurura muri sisitemu ya HVAC, bigatuma ahakorerwa umusaruro huzuzwa ibisabwa bisanzwe byisuku. Muri sisitemu yo kweza ikirere, kuyungurura ikirere muri rusange bigabanyijemo ibyiciro bitatu: mbere yo kuyungurura, kuyungurura hagati no kuyungurura hepa. Buri cyiciro gikoresha muyungurura ibikoresho bitandukanye. Prefilter niyo yo hasi kandi yashyizweho mugitangiriro cyikigo gikora ikirere. Irashobora gufata ibice binini mu kirere (ubunini buke buri hejuru ya microne 3). Hagati yo kuyungurura iri munsi yimbere ya pre-filter kandi igashyirwa hagati yikigo gishinzwe gufata ikirere aho umwuka wo kugaruka winjira. Byakoreshejwe mu gufata uduce duto (ingano ya microne 0.3). Iyungurura rya nyuma riri mubice bisohora igice cyogutwara ikirere, gishobora gutuma umuyoboro ugira isuku kandi ukongerera igihe cyumurimo wa filteri.
Iyo icyumba gisukuye urwego rwisuku ruri hejuru, hepa muyunguruzi ishyirwa hepfo yumurongo wanyuma nkigikoresho cyo kuyungurura. Igikoresho cyo kuyungurura itumanaho giherereye kumpera yikigo cyumuyaga kandi gishyirwa hejuru cyangwa kurukuta rwicyumba. Irashobora kwemeza itangwa ryumwuka mwiza kandi ikoreshwa mugutobora cyangwa kohereza ibice byasohotse mubyumba bisukuye, nkicyumba cyisuku cyicyiciro cya B cyangwa icyiciro cya A mubyumba B bisukuye.
(4) .Gucunga igitutu
Ibyumba byinshi bisukuye bikomeza umuvuduko mwiza, mugihe anteroom igana muri iki cyumba gisukuye ikomeza umuvuduko ukabije kandi ugabanuka, kugeza kurwego rwa zeru kurwego rwibanze rutagenzuwe (inyubako rusange). Itandukaniro ryumuvuduko hagati y’ahantu hasukuye n’ahantu hatari hasukuye no hagati y’ahantu hasukuye mu nzego zinyuranye ntigomba kuba munsi ya 10 Pa.Ibiba ngombwa, imashini zikoresha ingufu nazo zigomba gukomeza hagati y’ibikorwa bitandukanye (ibyumba bikoreramo) by’urwego rumwe rw’isuku. Umuvuduko mwiza ukomeza mucyumba gisukuye urashobora kugerwaho nubunini bwogutanga ikirere kuba kinini kuruta ubwinshi bwumwuka. Guhindura itangwa ryikirere birashobora guhindura itandukaniro ryumuvuduko hagati ya buri cyumba. Umusaruro udasanzwe wibiyobyabwenge, nkibiyobyabwenge cya penisiline, ahantu ukorera bitanga umukungugu mwinshi bigomba gukomeza umuvuduko mubi.
Igihe cyo kohereza: Ukuboza-19-2023